Maria F. Jaboli

PWE-174 A Proof Of Concept Assessment Of Non-invasive Vagus Nerve Stimulation (nvns) With Gammacore® In Patients With Gastroparesis Awaiting Enterra® Implantation

Introduction Vagal dysfunction has been implicated in gastroparesis. Gut vagal afferents convey symptoms of nausea, bloating and early satiety but the nerve also has an antinociceptive function. GammaCore (electroCore, LLC: New Jersey) is a CE marked hand-held vagus nerve stimulator designed to selectively stimulate afferent vagal A-fibres. It is possible that in gastroparesis, stimulation of the vagus nerve as it traverses the neck might influence symptoms. Methods Fifteen patients with severe gastroparesis awaiting Enterra (Medtronic, Minnesota) implantation agreed to a short proof of concept assessment of nVNS. Each patient was supplied with a GammaCore device programmed to deliver 150 doses, each dose lasting 90 seconds. The electrodes on the GammaCore device were positioned in line with the right cervical vagus nerve and stimulation applied three times daily. The gastroparesis multi-symptom questionnaire, that includes the symptoms of nausea, vomiting, early satiety and bloating, was completed daily for the week prior to starting treatment and daily throughout the treatment period. Symptoms were scored on a Likert scale (1 = none and 5 = severe). Composite and individual symptom scores were summated for the week preceding treatment and the final two weeks of the treatment period. Results Only seven of the 15 patients complied with the treatment regimen. In six patients, the diary score cards were incomplete and two patients did not use the GammaCore. Abstract PWE-174 Table 1 Symptoms (7 patients) Mean pre-treatment score (range) Mean score in final two weeks (range) Percent change Composite 34.7 (18.3–62.4) 27.49 (14.7–59.3) -21% Nausea 2.8 (0.6–4.7) 2.2 (0.5–4.3) -21% Vomiting 1.2 (0–5) 1.2 (0.1–5) 0% Early satiety 3.3 (2.1–5) 2.6 (1.7–5) -21% Bloating 2.4 (1.1–3.5) 1.7 (0.4–3.2) -29% Conclusion In this group of severely ill patients awaiting Enterra implantation, half complied with the treatment regimen. Compliant patients scored improvement in nausea, early satiety and bloating, as well as the composite gastroparesis score. This short term proof of concept assessment suggests that nVNS influences symptoms conveyed by vagal afferents. It is possible that stimulation of both left and right vagus nerves, increased stimulation amplitude, and a longer period of treatment might improve responsiveness. Future clinical trials are warranted to elucidate safety, efficacy, dose response and compliance. Disclosure of Interest None Declared.

Influence of Smoking and Other Environmental Factors in Inflammatory Bowel Disease Activity: What Do Our Patients Think?

Introduction It is widely accepted that smoking predisposes to Crohn9s disease (CD) but is protective against ulcerative colitis (UC). The precise impact of stress, the influence of diet and the efficacy of complementary medicines on the course of inflammatory bowel disease (IBD) are unclear (ECCO guidelines). The study aim was to assess our IBD patients9 knowledge about the association between IBD and smoking and to evaluate which factors they consider important in controlling bowel disease. Methods During a 6 weeks interval the authors prospectively recruited all patients attending the IBD clinic in our Institution. Patients were asked to complete an anonymous questionnaire which assessed basic demographics, smoking history and patient knowledge about their disease. Patients were asked to rank (in a scale from 0 to 10) the importance, in their opinion, of the following factors in controlling IBD activity: drugs, surgery, diet, stress control, stopping smoking and alternative therapy. Results The authors surveyed 199 patients (median age 44 years; M/F: 92/107) with IBD: 101 (51%) had CD, 86 (44%) had UC and 12 (5%) had IBD-unclassified. Median IBD duration was 12 years (range 1–60). 89% of CD patients were non-smoker compared to 95% of UC (p=0.015). 69% of CD patients reported to be aware of the negative association between smoking and CD; while only 36% of UC patients were aware of the positive association with UC. CD patients rated medications (mean value 7.8), followed by stress control (7.6) and even diet (7.4) as the most important factors able to influence their disease activity. Smoking cessation (7.0) and surgery (6.5) were considered less effective. Alternative treatment (3.6) was considered only marginally effective in IBD. There was a strong correlation between stress and diet (p Conclusion Only two thirds of CD patients recognise the importance of smoking cessation on disease activity, and one third of UC patients are aware of the positive association with smoking. IBD patients consider stress and diet as effective as drugs in controlling bowel disease; moreover, CD patients value stress and diet as more important than smoking in affecting disease activity. Clinicians should always consider the perceptions and beliefs of the patient when discussing treatment strategy in IBD.

OC-069 Non-invasive afferent vagus nerve stimulation (nvns) using gammacore (gc) in patients with treatment refractory gastroparesis awaiting enterra gastric neurostimulation

Introduction High frequency, low energy gastric neurostimulation (EnterraTM) is indicated for compassionate treatment of patients with refractory gastroparesis. Symptom improvement is reported in 50–60% of patients but not accompanied by improved gastric emptying. It is likely that gastric neurostimulation affects the gut-brain axis influencing autonomic afferents.1GammaCore (electroCore, LLC) is a non-invasive, afferent selective vagus nerve stimulator (nVNS) used for the treatment of migraine and cluster headache.2We report the first use of gammaCore (gC) in patients with refractory gastroparesis. Method 35 consecutive patients with intractable gastroparesis were invited to undergo a course of gC whilst awaiting funding for Enterra. The gC device delivers its stimulus to afferent vagus fibres as they cross the neck adjacent to the carotid arteries and it is programmed to deliver doses of 120 s. Patients were trained to deliver 2 doses (240 secs) to the left and right vagus nerve respectively. This dosing regimen was self-administered 8 hly (12 doses/day) for 2 weeks, increasing in week 3 to 3 doses 8 hly (18 doses/day). Patients were asked to grade their symptoms daily using the 9 item Gastroparesis Cardinal Symptom Index (GCSI) with a 5 point Likert scale. The GCSI was completed for 2 weeks prior and throughout the treatment period. At the end of the treatment period, the mean aggregated GSCI score at baseline was compared with the score of the final week of treatment. Clinically meaningful improvement was defined as a GCSI Likert scale reduction of ≥1. Results Twenty-three of the 35 patients (65.7%) used the gC as instructed and completed the diary. At 3 weeks, 8 patients (35%) had a ≥1 reduction in the aggregated GSCI score. Two patients who continued stimulation for more than three weeks had a delayed response, giving a total response rate of 43%. The response was evident within 1 week of commencing treatment in 8/10 responders (80%) and there was symptom recurrence within a week of stopping treatment in all the responders. There were no significant adverse events. Conclusion In this group of patients with treatment refractory gastroparesis, 1/3 failed to engage with short term nVNS. In compliant patients,43% recorded a fall of ≥1 in their aggregated GCSI score. As gC stimulates afferent vagus fibres, it is likely that the response is mediated at the level of the gut-brain axis. In refractory gastroparesis, gC might offer a new approach to symptom control. The dosing and duration of nVNS required to obtain an optimal response deserves further consideration. Disclosure of interest None Declared. References McCallum RW, et al. Neurogastroenterol Motil. 2010;22(2):161–7 Goadsby P, et al. Cephalgia 2014;34(12):986–93

Tu1088 Looking for Satisfaction in NHS - Patients, GPS and Specialist Doctors

Introduction In NHS it is time for innovation. Instead of patients suffering the long waiting times and a multitude of journeys to and from hospital, they should receive a diagnosis with immediate treatment within a month of referral. Hospitals are under pressure to achieve targets and need to improve their communication with patients and GEneral Practitioner (GP). A new type of Outpatient clinic, the Split Clinic (SC), in Gastroenterology has been piloted and feedback from the patients and GP obtained. Method Questionnaires about the quality of the consultation they received in the SC, were issued to 118 patients. The referrals were previewed and investigations pre-booked after contacting the patients. Patients return home with a “Easy View Care Map” (EVCM) document which summarises the consultation in a Mind Map format. The questionnaire asked four simple questions with five options (from strongly agreed to strongly disagree). A second survey was undertaken to assess the acceptability to GPs of the EVCM. 266 questionnaires were sent out to all the GPs containing seven questions and same five reply options. Results The responses of the 118 patients are summarised in Table 1. 110 of 266 (41%) of the GP questionnaires were returned. The responses are summarised in Table 2. Conclusion We think that the SC is an innovative clinic because the patients liked the fact that it was well organised, efficient and saved them time. GPs approved the new EVCM document. We, as providers of the NHS, found great satisfaction delivering diagnosis and treatment in one morning instead of 3 months. Overall quality of life is improved together with cost savings. Disclosure of interest None Declared.

Mo1094 The Split Clinic – A Prescription for Efficiency in the Gastroenterology Outpatient Clinic

Introduction Worldwide, healthcare providers are striving to balance escalating costs with the patient’s expectation of efficient access to specialist opinion, rapid investigation and treatment. Over the past 65 years, the NHS gastroenterology outpatient journey has remained unchanged. Patients are assessed at the first visit, followed by one or more hospital visits for gastrointestinal investigations and a return hospital visits for final assessment. The split clinic has been designed, wherever possible, to condense the journey from weeks or months to hours. Methods Over a period of three months, each gastroenterology referral letter was previewed four to six weeks prior to the outpatient appointment, and each patient was triaged as “Solution” and “Complex”. For the solution cohort, investigations were predicted and booked for the same day as the outpatient visit. The patients were asked to attend clinic starved and told to expect one or more same day gastrointestinal investigations. On the appointment day, “Solution” patients attended the split clinic for an initial assessment, then proceeded to investigation, returning thereafter to the clinic for feedback. Results Of 174 referrals, 95 patients were triaged from the referral letter as “Solution” patients, and 81 attended the split clinic (7 did not arrive, 4 postponed, 3 direct to surveillance colonoscopy). In those who attended, 46 same day tests were performed (14 upper endoscopies, 11 sigmoidoscopies, 5 barium swallows, 6 Eso Capsule endoscopies, 5 ultrasound scans, 1 electrogastrogram, 2 CT abdomen and 2 CT colonoscopy). Twenty-seven patients (34%) were discharged, and twenty-two (27%) were discharged after a single follow up telephone consultation. Overall, 49 patients designated as “Solution” patients (60%) required only a single hospital visit. Sixteen patients (17%) were re-designated as “Complex” requiring further tests and 3 (3%) were referred elsewhere. Overall, 95 (46 same day tests and 49 return to follow up clinic in old system) return hospital visits were avoided and the attended to discharged ratio was 81:27 (1:0.3). Conclusion Analytical triage of GP referral information allows identification of most gastroenterology “Solution” patients. This facilitates pre-emptive investigation planning and scheduling which, in turn, supports a split clinic designed to condense weeks or months of investigation and follow up into a few hours. The well planned split clinic meets the patient’s expectation for an efficient journey, quick diagnosis and reduced number of hospital visits. Disclosure of Interest None Declared.

PTH-100 Psychological Morbidity and Provision of Psychological Support in the Inflammatory Bowel Disease Clinic

Introduction Inflammatory bowel disease (IBD) can have a significant impact on physical, psychological and social wellbeing. We aimed to survey the impact of IBD on our patients’ lives and their perceptions of psychological support use and availability. Methods Inflammatory bowel disease (IBD) can have a significant impact on physical, psychological and social wellbeing. We aimed to survey the impact of IBD on our patients’ lives and their perceptions of psychological support use and availability. Results 6 patients were excluded as they had not completed the questionnaire. 94 patients were included (43 male, 51 female, average age 42 years, range 17–76). 46 had a diagnosis of Crohn’s disease, 41 ulcerative colitis and 7 indeterminate colitis. Average disease duration for these patients was 15 years (range 1–51 years). Over the past 6 months 20 had symptoms constantly, 16 often, 17 occasionally, 10 sometimes, 13 rarely and 18 never. The average SIBDQ score was 48 (range 21–70). The average HAD score was 12.6 (range 0–33). When separated into HAD A (anxiety) and HAD D (depression) scores were 8.1 (range 0–18) and 4.8 (range 0–15) on average respectively, a score of 8 to 10 for either subscale being suggestive of the presence of the respective state. They were also asked which services they had previously used as forms of support. Of the 86 patients who answered this portion of the questionnaire, 13 (15%) said they had previously had counselling or psychological input, and 32 (37%) said they would like counselling or psychological input in the future if it was available. Conclusion Our survey suggests there may be a higher rate of anxiety in patients with IBD, and that over a third of our patients would like access to psychological and counselling services if they were available. Psychological support is important to patients with IBD and should be incorporated into their management. Disclosure of Interest None Declared.

PTU-113 Quality of life in patients with ileoanal pouch: a survey comparing two different patient populations

Introduction Ileal pouch anal anastomosis (IPAA) is the standard restorative procedure for ulcerative colitis (UC) following colectomy. This operation is, however, associated with distinct rates of failure and complications. We performed a survey to evaluate the quality of life (QoL) after IPAA comparing patients followed up in two different teaching Hospitals in London (L), UK and Bologna (B), Italy. Methods A total of 126 (71L+55B) UC patients received the questionnaire by mail or during clinic. The questionnaire was done according to the IBDQ and it was designed to assess pouch function, disease-specific adjustment, lifestyle aspects and psychological factors. 85 (43L+42B) patients (67%) returned it (M/F= 46/39; age 41±16 years); average pouch duration was 5–7 years. Results There was no significant difference between L and B in terms of age, gender, marital status, pouch duration, bowel frequency (median 3–6 motions per day and 1–2 per night), experience of leakage (30% more than once a week) and need of additional surgery (0.05%). In L there were significantly more patients who had at least one episode of pouchitis (72%) compared to B (33%). L used significantly more alternative remedies (L 11% vs B 0%), antimotility drugs (L 44% vs B 30%), antibiotics (L 65% vs B 29%) and steroids (L 16% vs B 7%). No difference in immunosuppressant (18%) and VSL#3 use (22%). L patients regret having IPAA significantly more frequently (L 13% vs B 0.02%), cope less with the stoma (in L 39% hated it vs 0% in B), suffer more of unpredictability (L 51% vs B 19%), are less capable to hold the stool for more than 1 h (L 62% vs B 88%) and have more worrying thoughts (L 30% vs B 9%). B patients play sport significantly more frequently (B 76% vs L 53%). L and B reported similar QoL, well being, cheerfulness, ability to work, go on holiday and enjoy things they used to do; similar confidence in doing whatever they want and level of concern in finding a toilet. Conclusion Our survey showed that in London patients developed more pouchitis and therefore used more medications. They cope worse with the pouch and regret more having had surgery. Interestingly in Italy patients play more sport, but the overall quality of life was the same. Extent and severity of disease prior to surgery, smoking and association with primary sclerosis cholangitis may play a role in the increase incidence of pouchitis in London, but these data were not available in our anonymous questionnaire. Different biologic behaviour and/or genetic background may contribute in this difference. Competing interests None declared.

Prospective comparison of different gastric motility tests in dyspeptic patients

Introduction Up to 60% of dyspeptic patients have a normal upper endoscopy. Endoscopy is unable to diagnose myoelectrical disorders which can cause dyspeptic symptoms including epigastric discomfort, early satiety, bloating, nausea and vomiting. Although patients with functional dyspepsia complain of epigastric symptoms, the relation between these symptoms and gastric motility remains controversial. Electrogastrography (EGG) is a simple, non-invasive method for assessing the gastric pacemaker slow wave. Gastric emptying study (GES) is typically the first test in evaluation of gastric motor function using a radiolabelled test meal. The ultrasound of the stomach (USS) is a recent non-invasive and cheap modality to evaluate gastroduodenal motility. We wanted to compare the information given by three different gastric motility tests in patients with endoscopy negative dyspepsia (END). Methods A series of 77 dyspeptic helicobacter pylori negative patients (60 female: 17 male, ages 18–65 years) diagnosed according to the Roman III criteria and a normal upper endoscopy, underwent a standard fasting and postprandial EGG, a technetium labelled mashed potato GES and an ultrasound of the stomach given a soup test meal. The EGG was considered abnormal if <70% of slow wave activity was recorded at 3 cycles/min. Delayed or increased gastric emptying was diagnosed if the T½ for the test meal was outside the normal range for our unit (<15 or >45 min, respectively). The USS was considered normal if the gastric emptying rate was between 45% and 78%. Results Thirty-one (40%) patients had both GES and USS test showing gastroparesis with mainly symptoms of nausea and vomiting (20/31, 64%). Eighty per cent (25/31) of these patients had an abnormal EGG, having as a predominant pattern an abnormal pre and post prandial test (12/31, 38%). Interestingly 17 people (22%) had normal GES and USS, with abnormal EGG in 82% of patients (14/17). Ten of these patients (58%) were experiencing nausea and vomiting as well. Only 2 (2.5%) patients had findings of dumping syndrome on GES and USS. There was more heterogeneity in the results of these tests with patients referring bloating and epigastric discomfort. Conclusion In patients with endoscopy negative dyspepsia, gastroparesis is very common and particularly with symptoms like nausea and vomiting. GES and USS can provide a firm diagnosis and possibly influence treatment strategies. We think these investigations should be incorporated into dyspepsia guidelines at the point where endoscopy is reported as normal. We are currently investigating the role of EGG for the poor correlation with the other tests.